Posted by Michael Wonder on 22 Nov 2019
FDA grants breakthrough therapy designation to Usona Institute's psilocybin program for major depressive disorder
22 November 2019 - Usona Institute has received breakthrough therapy designation from the US FDA for psilocybin in the treatment of major depressive disorder.
Breakthrough therapy designation establishes FDA’s organisational commitment to promoting an efficient development program for psilocybin in major depressive disorder.
The new status follows the recent launch of Usona’s Phase 2 clinical trial, PSIL201, which will include approximately 80 participants at seven study sites around the US. Two of the seven study sites are currently recruiting, with the others expected to be active by the first quarter of 2020.
